Cleared Traditional

K934620 - ORTHOLOC ADVANTIM FIXED STEM NON-POROUS TIBIAL BASE

K934620 is an FDA 510(k) clearance for ORTHOLOC ADVANTIM FIXED STEM NON-POROUS..., manufactured by Wrightmedicaltechnologyinc. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 339-day FDA review.

K934620 · Wrightmedicaltechnologyinc · Orthopedic device
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Sep 1994
Decision
339d
Days
Class 2
Risk

K934620 is an FDA 510(k) clearance for the ORTHOLOC ADVANTIM FIXED STEM NON-POROUS TIBIAL BASE. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on September 1, 1994 after a review of 339 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3560 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Wrightmedicaltechnologyinc devices

FDA 510(k) Submission Details - K934620

510(k) Number K934620 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1993
Decision Date September 01, 1994
Days to Decision 339 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
217d slower than avg
Panel avg: 122d · This submission: 339d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JWH Device Classification - Class 2, Special Controls

Product Code JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3560
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

All 895
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K934620.
ORTHOLOC ADVANTIM REVISION FEMORAL COMPONENT
K932210 · Dow Corning Wright · Sep 1994
ECACTECH POROUS COATED FINNED TIBIAL TRAY COMPNENT
K936079 · Exactech, Inc. · Sep 1994
ORTHOLOC ADVANTIM
K933290 · Wrightmedicaltechnologyinc · Sep 1994
THICK TIBIAL INSERT
K933289 · Wrightmedicaltechnologyinc · Aug 1994
LINE EXTENSION FOR KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM, POROUS COATED
K933843 · Kirschner Medical Corp. · Aug 1994
FOUNDATION METAL-BACKED PATELLA
K932246 · Encore Orthopedics, Inc. · Jul 1994